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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K201296
Device Name i-Rapha Solution
Applicant
Irm, Inc.
4th-D, Myung-Woo Bldg, 169, Yeoksam-Ro
Gangnam-Gu,  KR 06247
Applicant Contact Kim Yun Ik
Correspondent
Irm, Inc.
4th-D, Myung-Woo Bldg, 169, Yeoksam-Ro
Gangnam-Gu,  KR 06247
Correspondent Contact Kim Yun Ik
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/15/2020
Decision Date 07/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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